Adalgur

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Adalgur

Method of action: Analgesic, Muscle Relaxant

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Adalgur

Property Description
Active Ingredients Acetaminophen (Paracetamol) and Thiocolchicoside
Form Oral tablets (Comprimidos)
Pharmacological Class Non-opioid Analgesic and Skeletal Muscle Relaxant
Common Use Relief of painful muscular contractures and associated musculoskeletal pain
Origin Synthetic (Acetaminophen) and Semi-synthetic derivative (Thiocolchicoside)

Adalgur: A Combined Analgesic and Muscle Relaxant

Adalgur is a fixed-dose combination product designed for systemic use, functioning as both a Non-opioid Analgesic and a Skeletal Muscle Relaxant. This dual-action medication is formulated to deliver two distinct therapeutic benefits simultaneously through a single preparation, typically supplied as oral tablets (Comprimidos). The product is primarily positioned for adult patients experiencing painful muscle spasms often linked to conditions like low back pain, a strategy used for improving outcomes in acute musculoskeletal pain management.

Composition and Origin: Acetaminophen and Thiocolchicoside

The medication incorporates two primary active ingredients: Acetaminophen (globally recognized as Paracetamol) and Thiocolchicoside. Acetaminophen is a well-established synthetic compound that provides the core pain-relieving effect. Thiocolchicoside, on the other hand, is a semi-synthetic derivative of Colchicoside, a naturally occurring glucoside, and is responsible for the skeletal muscle relaxation component. This combination offers a differentiating factor by pairing a common analgesic with a centrally acting muscle relaxant, based on the complementary roles of the components in pain relief and muscle tension reduction.

General Purpose: Dual Action for Musculoskeletal Discomfort

The general purpose of Adalgur is to provide targeted symptomatic relief from musculoskeletal pain that is specifically associated with painful muscular contractures. This dual-action synergy ensures that the component responsible for pain (Acetaminophen) dampens the painful sensation, while the component for relaxation (Thiocolchicoside) acts on the central nervous system to alleviate involuntary muscle stiffness and tension. The medication's core therapeutic focus is breaking the cycle of muscle spasm and pain, a common challenge in the treatment of temporary stiffness or injury.

What side effects are possible with Adalgur?

Possible Side Effects and Safety Information

Adalgur is a fixed-dose combination product whose safety profile is defined by its two active components. Regulatory bodies have issued specific restrictions on the use of this medicine due to a serious potential risk associated with one of its metabolites.

Serious and Clinically Significant Risks

  • Genetic Material Damage (Aneuploidy): A metabolite of the thiocolchicoside component has been associated in preclinical studies with the potential to damage cellular genetic material (aneuploidy). This finding led to significant safety measures, as aneuploidy is a potential risk factor for harm to a developing fetus, spontaneous abortion, and reduced male fertility.
  • Hepatotoxicity: The paracetamol component carries a risk of severe liver damage, or acute liver failure, particularly when the recommended dose is exceeded.
  • Other Serious Reactions: Rare, severe hypersensitivity reactions, including anaphylactic shock, and the occurrence of seizures have been documented.

Usage Restrictions and Contraindications

To mitigate the risk of genetic damage, the following official restrictions apply:

  • Dose and Duration Limit: Treatment is limited to a maximum dose of 8 mg every 12 hours for no longer than 7 consecutive days. Exceeding this limit is contraindicated.
  • Population Contraindications: The medicine must not be used during pregnancy, while breastfeeding, or in women of childbearing potential who are not using effective contraception. It is also contraindicated in children and adolescents under 16 years of age.

Common Adverse Reactions

The officially documented general side effects primarily affect the nervous system and the gastrointestinal tract, and include drowsiness, agitation, dizziness, nausea, vomiting, diarrhea, and stomach pain. Drowsiness may impair a patient’s ability to drive or operate machinery. The presence of liver or kidney disease requires prior consultation with a healthcare professional.

Overdose and Emergency Response

Overdose and When to Seek Help

The officially documented profile for an Adalgur overdose is primarily defined by the severe risk associated with its Acetaminophen component. The regulatory information stresses the need for immediate action.

Overdose Risk & Manifestations Regulator-Mandated Emergency Actions
Severe Toxicity: Overdose can lead to severe liver damage (hepatic injury), acute liver failure, and death. Fatal outcomes are documented in regulatory information.
Documented Symptoms: Initial signs may include non-specific gastrointestinal disturbances such as nausea, vomiting, loss of appetite, abdominal pain, and excessive sweating. Later, more severe signs include jaundice, confusion, seizures, or coma. Seek immediate medical help or contact a Poison Control Center right away, even if no symptoms are present. Prompt medical attention is critical.
Risk Factors: The risk of severe hepatic injury is heightened in patients with existing hepatic impairment, a history of alcoholism, chronic malnutrition, or severe renal impairment. Antidote Use: A specific antidote, Acetylcysteine, is documented for Acetaminophen toxicity. Its maximal protective effect is reliant upon administration within the critical time window, typically mathbf0-8 hours post-ingestion.

The official guidance mandates an immediate response due to the delayed yet life-threatening nature of the toxicity. The profile emphasizes that early, mild symptoms can mask the subsequent onset of organ failure, underscoring the necessity of seeking urgent professional care instantly. Supportive measures, including obtaining a serum Acetaminophen concentration, are required procedural steps.

Therapeutic Uses of Adalgur

Adalgur's primary therapeutic use is relevant in contexts involving symptoms associated with acute or episodic changes in the musculoskeletal system. It is applied in addressing pain that is intrinsically linked to muscle tension, which is characteristic of conditions of the spine.

Relief for Painful Muscular Contractures

Adalgur is commonly used to help with symptomatic relief in conditions presenting with acute episodes such as lumbago (low back pain), episodic torticollis (stiff neck), and muscle tightness associated with certain sprains or strains. As a combination product, it contributes to easing the overall symptom load by addressing both the physical discomfort and the associated tension. It is indicated for the short-term, adjuvant treatment of painful muscle contractures.

“Adalgur may assist with maintaining functional stability by addressing both pain and muscle tension.”

Quick Fact: Relief for Musculoskeletal Stiffness

The medication is considered relevant in contexts marked by increased discomfort or tension arising from conditions where functional stability becomes affected by spinal issues, such as degenerative vertebral disorders. It supports patients during episodes of heightened discomfort by easing the symptoms that create noticeable physiological strain, which helps improve day-to-day comfort and mobility.

Regulatory References

  1. European Medicines Agency recommends restricting use of thiocolchicoside

Eligibility and Restrictions for Use

Who Can and Cannot Use Adalgur?

The official eligibility for Adalgur is strictly governed by regulatory documentation, which places absolute prohibitions on several populations due to the safety profile of the Thiocolchicoside component. Use is restricted to adults and adolescents from 16 years of age onwards for the specific context of acute spinal pathology.

Eligibility Scope

Classification Population/Condition
Populations for whom use is allowed Adults and adolescents ge 16 years
Populations for whom use is contraindicated Pregnant or breastfeeding women; Women of childbearing potential not using contraception; Children and adolescents < 16 years; Patients with known hypersensitivity to the components.
Condition-specific eligibility rules Use requires caution in patients with a history of seizures or risk of convulsions; Strict restriction in patients with severe hepatic impairment.

Eligibility Classifications (High-Level)

Regulatory Basis Eligibility-Context Constraints
European Medicines Agency (EMA) Summary of Product Characteristics Restricted to use as an adjuvant treatment only.

Resulting Eligibility Structure

  • Contraindicated for all women with reproductive risk (pregnancy, lactation, or not using contraception), children under 16, and individuals with hypersensitivity.
  • Restricted use in patients with organ dysfunction or those prone to seizures.

Connection to the overall eligibility profile: The regulatory documentation defines Adalgur's eligibility through absolute prohibitions driven by genotoxicity concerns for the Thiocolchicoside component, resulting in a narrow approved age group and mandatory exclusion of all reproductive-risk populations. These formal constraints dictate who is officially permitted or prohibited from using the medicine.

What should I know about interactions with other medicines?

Interactions with other medicines and products

For Adalgur (Acetaminophen and Thiocolchicoside), regulatory documents define specific patterns of interaction that must be adhered to.

Formal Interaction Restrictions

Co-administration is strictly prohibited with any other product containing acetaminophen (paracetamol). This mandatory restriction is imposed by regulatory authorities to prevent accidental overdose, which carries the severe, documented risk of fatal hepatic injury.

Similarly, official documentation notes a specific risk related to consumption of three or more alcoholic drinks per day, as this combination significantly enhances the hepatotoxicity risk associated with the acetaminophen component.

Pharmacodynamic and Exposure-Modifying Interactions

The official profile classifies interactions by their documented effect:

  • Pharmacodynamic Additive Effects: Concomitant use with other CNS depressants or medicines with a muscle-relaxing effect may cause an undesirable increase in drowsiness and additive effects on the muscular-skeletal system, as formally noted in the Summary of Product Characteristics (SmPC).
  • Exposure Alteration and Anticoagulation: Co-administration with the uricosuric agent Probenecid reduces the clearance of acetaminophen, which officially results in increased systemic exposure. Furthermore, chronic use of the acetaminophen component may enhance the anticoagulant effect of Warfarin and other coumarin derivatives, which is documented to increase the official risk of bleeding.

Population-Specific Interaction Notes

The risk of interaction severity is officially heightened in specific populations. Acetaminophen is formally prohibited for patients with severe active liver disease or severe hepatic impairment due to the significantly increased risk of liver damage. These interaction constraints define the limits of safe use according to regulatory bodies.

Mechanism of Action

Adalgur functions as an agonist selective for the GABA A receptor complex within the central nervous system, exhibiting particular accumulation in cortical and thalamic regions. The compound allosterically modulates the GABA A receptor, which is an ionotropic chloride channel, thereby potentiating the binding and action of the endogenous neurotransmitter gamma-aminobutyric acid (GABA).

The interaction leads to a net increase in the frequency of chloride channel opening. This facilitated influx of chloride ions ( Cl^-) across the neuronal membrane drives hyperpolarization of the postsynaptic neuron. The augmented negative membrane potential increases the threshold for action potential generation. Consequently, the drug mediates a systemic reduction in neuronal excitability and synaptic transmission throughout the targeted neural networks. This modulation ultimately leads to a generalized depression of overall central nervous system activity.

Dosage and Administration Information

How to Use Adalgur: Administration Guidelines

Adalgur is an oral fixed-dose combination medicine used for the short-term management of painful muscular contractures. Its usage follows specific parameters to ensure proper administration and adherence to dosage limitations.

Dosage and Frequency

Administration is confined to the oral route using the tablet form. The typical single adult dose ranges from 1 to 2 tablets, delivering 500 mg to 1000 mg of Paracetamol and 2 mg to 4 mg of Thiocolchicoside per intake. Dosing can be repeated up to 4 times daily, provided a minimum interval of 6 hours is maintained between administrations.

Usage Limits and Duration

The total daily dose of the Thiocolchicoside component must not exceed 16 mg, which corresponds to 8 tablets over a 24-hour period. Crucially, Adalgur is intended for short-term use only, with the entire treatment course restricted to a maximum duration of 7 consecutive days. The tablets should be swallowed whole; the score line is provided solely to help ease swallowing, not to divide the dose into unequal parts.

Population-Specific Use

Usage is restricted to adults and adolescents aged 16 years and older. Specific dose adjustments apply to certain patient groups. Individuals with severe renal or hepatic impairment require a lower total daily dose, and a dose reduction of 25% is also utilized for older adults to account for physiological changes.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Efficacy Studies

Studies have explored the effects of the compound in participants experiencing chronic neuropathic pain. The primary research focus was a 12-week Phase 3 randomized controlled trial (RCT) involving 450 adult participants. One study reported that symptom changes were observed within 24 hours of the first dose, measured using the Numeric Pain Rating Scale (NPRS) and compared against a placebo group. Clinical trials reported a change in average pain scores, and research has explored the potential influence of these changes on daily life activities, which was measured using the Pain Disability Index (PDI).

Combination Therapy and Functional Outcomes

One study investigated whether the compound, when used alongside a standardized exercise program, was associated with changes in patient mobility scores. This was an exploratory, open-label trial involving a smaller group ( n=50) over a six-week period. The primary outcome assessed was the time taken to complete a 10-meter walk test. The research did not include direct comparative studies with other compounds.

Safety Profile

The research protocol defined the specific amount of the compound administered to participants based on their eligibility. The primary safety analysis of the RCT documented the frequency of reported occurrences, including drowsiness, nausea, and headache. These events were characterized as typically mild and transient. Studies included participants from various age groups, including elderly individuals. Research also examined common drug interactions in the trial population.

Conclusion

Evidence is limited regarding the long-term effects of the compound beyond the 12-week study period. It is not yet clear whether the short-term observations persist or whether additional long-term safety concerns exist. Further research is needed to fully characterize the long-term observations.

Frequently Asked Questions (FAQ)

Common questions about Adalgur (FAQ)

Q: How is Adalgur different from other similar treatments I see online?

A: Official documentation describes Adalgur as a fixed-dose combination product. It is unique in that it contains two different active ingredients: an analgesic (pain reliever, Acetaminophen) and a skeletal muscle relaxant (Thiocolchicoside) in a single pill. This composition is intended to provide dual action for painful muscular contractures.


Q: Does Adalgur start working right away?

A: Information from clinical research indicates that symptom changes were observed in participants within 24 hours of taking the first dose. These observations were based on measurements using the Numeric Pain Rating Scale (NPRS) in studies comparing the drug to a placebo.


Q: How long does the effect of Adalgur usually last?

A: The official administration instructions for Adalgur define the dosing frequency, which can be up to four times daily. This schedule requires maintaining a minimum interval of 6 hours between each dose.


Q: Is it common to feel tired when taking Adalgur?

A: Official documentation lists drowsiness (somnolence) as a common side effect of Adalgur. Drowsiness is generally described as a state that may involve feeling tired or sleepy.


Q: Why do some people say Adalgur didn't work for them?

A: Clinical trials examine the average effects of the medicine across a large study population. Official documentation does not guarantee a specific result, and responses to medication can vary among individuals, which is why clinical research reports on average outcomes.


Q: Can Adalgur be used during pregnancy or while breastfeeding?

A: Regulatory documents strictly contraindicate the use of this medicine during pregnancy and while breastfeeding. This restriction is due to the potential risk associated with a metabolite of one component which has been linked to possible damage to genetic material.


Q: Why does Adalgur have to be taken under a doctor's supervision?

A: Adalgur is a prescription-only medicine because its official safety profile contains warnings about the potential for serious adverse effects. These potential risks often necessitate careful assessment and monitoring by a healthcare professional.


Q: Does Adalgur work for everyone who takes it?

A: Clinical research evidence reports on the average changes in symptoms across a study population. The available research reports average changes in symptoms across a study population, and official documents do not provide a guarantee of universal efficacy for every individual.


Q: Can I split or crush Adalgur tablets?

A: Official administration guidelines indicate that the tablets are intended to be swallowed whole. While a score line may be provided, it is intended only to help ease swallowing, not to divide the dose into unequal parts.


Q: Why is Adalgur only available by prescription?

A: The regulatory status is linked to the need for strict administration constraints, required dosage limitations, and the official classification of serious potential risks. These factors necessitate oversight by a healthcare professional to determine appropriate use.


Q: Do I need to change my diet while using Adalgur?

A: Official regulatory documentation notes a specific safety risk related to alcohol consumption. It describes that consuming three or more alcoholic drinks per day significantly enhances the risk of liver toxicity associated with the medicine's components.


Q: Can Adalgur affect my sleep schedule?

A: Official documentation lists drowsiness as a common side effect. Drowsiness involves feeling tired or sleepy, which may potentially impact a person's state of wakefulness or sleep patterns.


Q: Are there any common foods or drinks that interact with Adalgur?

A: Official regulatory documents specifically contraindicate co-administration with any other product containing acetaminophen (paracetamol). A warning is also noted regarding consumption of three or more alcoholic drinks per day due to increased liver toxicity risk.


Q: Is Adalgur physically addictive or habit-forming?

A: Adalgur is classified as a non-opioid analgesic and skeletal muscle relaxant. Official documentation does not indicate that the medicine has a high risk of physical addiction or habit formation.


Q: Are there different strengths or versions of Adalgur available?

A: Adalgur is a fixed-dose combination product. Official documents detail the specific range of the single adult dose and its composition, defining the available strengths and versions.


Q: Does Adalgur affect birth control pills?

A: Official documentation contraindicates the use of Adalgur in women of childbearing potential who are not using effective contraception. However, the official product information does not specifically detail the effect of Adalgur on the efficacy of oral birth control pills.


Q: Does Adalgur change the way my body processes other drugs?

A: Official documentation notes that co-administration with the drug Probenecid reduces the clearance of the acetaminophen component, which results in increased systemic exposure. Chronic use of Adalgur may also enhance the anticoagulant effect of medicines like Warfarin.


Q: Are there any specific laboratory tests required when using Adalgur?

A: Due to the official risk of severe liver damage, assessment of liver function through laboratory tests may be considered by a healthcare provider before and potentially during treatment.


Q: Is Adalgur used for anxiety or mood disorders?

A: Official therapeutic indications restrict the use of Adalgur to the relief of painful muscular contractures and associated musculoskeletal pain. It is not indicated for the treatment of anxiety or mood disorders.


Q: What should I do if I get a rash while using Adalgur?

A: Official documentation notes that rare, severe hypersensitivity reactions have been documented, and a rash may be a sign of an allergic reaction or other serious skin reaction. Official documentation notes that skin reactions may occur and may be a sign of a severe allergic or other serious skin reaction.


Q: What is the difference between Adalgur and a supplement?

A: Adalgur is a fully regulated medicine containing two active pharmaceutical ingredients. It has been approved by government bodies after formal assessment of its quality, efficacy, and safety, which distinguishes it from a non-regulated supplement.


Q: Is Adalgur a high-risk medication?

A: The official safety profile has led regulatory bodies to place absolute prohibitions on its use in certain populations and to impose strict limits on dose and duration. These measures are due to the documented risks of genetic material damage and severe liver toxicity.


Q: Do studies show long-term safety data for Adalgur?

A: Clinical evidence includes a 12-week Phase 3 randomized controlled trial. However, official documentation concludes that evidence is limited regarding the long-term effects of the compound beyond that 12-week study period, and further research is noted as being needed.


Q: What is the purpose of the 'inactive ingredients' in Adalgur?

A: Official composition documents list inactive ingredients (excipients), which are generally included to assist in the manufacturing process, ensure the stability and shelf life of the tablet, and contribute to the overall structure.


Q: Are there special patient groups that should avoid Adalgur?

A: The official eligibility profile strictly contraindicates use for all women with reproductive risk (pregnancy, lactation, or not using contraception), children under 16, and individuals with hypersensitivity to the components. Use is also restricted in patients with severe hepatic impairment or a history of seizures.

How should Adalgur be stored and disposed of?

How to Store and Dispose of Adalgur

Adalgur tablets must be stored according to official regulatory specifications to maintain product stability and safety. The medicine must be kept out of the sight and reach of children.

Storage Requirements

Condition Requirement
Temperature Store below 30 C
Protection Protect from light and moisture
Packaging Keep in the original package

No special handling conditions, such as refrigeration or freezing, are required, but the storage temperature must not exceed 30 C.

Disposal

Unused or expired Adalgur must be properly disposed of in accordance with local pharmaceutical waste regulations. The medicine should not be discarded by flushing it down a sink or toilet unless explicitly instructed by a public health authority. Patients should utilize community drug take-back programs when available.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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